Project: Characterization of Fiber-Based Scaffolds
Type: STandards Advancement Project
PARTNERS: ASTM International, ARMI | BioFabUSA, National Institute of Standards and Technology (NIST), and the SCB Tissue Engineering Sector Working Group
Get Involved:Standard published: additional needs TBD
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DESCRIPTION:
Fiber-based scaffolds have the potential to more closely mimic the properties of functional tissue than a scaffold with a regular repeating pattern. As a result, they are being used and considered for a wide variety of tissue engineering applications. To ensure their quality and safety, the regenerative medicine community would benefit from standards for measuring the structural, mechanical, and biological properties of fiber-based scaffolds. ASTM held a May 2013 workshop on standards and measurements for tissue engineering scaffolds to identify needed standards in this area, including needs specific to characterization of fiber-based scaffolds.
To re-energize this 2013 scaffolds standards and measurement effort, SCB coordinated a working group of approximately 30 experts from industry, government, and academia to identify fiber‑based scaffold standards gaps and develop an ASTM International standard focused on the characterization of fiber-based scaffolds.
PROGRESS:
(learn more about the standards advancement process)
Note: Projected start dates are estimates only. Development of a standard depends on SDO timelines, which can vary.
Convened In-Person Workshop: In partnership with NIST, ARMI | BioFabUSA, and ASTM International Committee F04 on Medical and Surgical Materials and Devices, SCB hosted a Characterization of Fiber-Based Scaffolds workshop in August 2018. Workshop discussions focused on fiber-based scaffold characterization, batch-to-batch variability, measurement validation, and release criteria.
Coordinated Fiber-Based Scaffolds Working Group: Based on workshop results, SCB has assembled and guided the fiber-based scaffolds working group through the drafting of an ASTM International standard. The draft standard (ASTM WK65476: New Guide for Characterizing Fiber-Based Constructs for Tissue Engineered Medical Products) was discussed at the May 2019 ASTM International Committee F04 meeting and was revised and submitted for ballot in the summer of 2020.
Finalized Draft: The standard was published as ASTM F3510 – 21: Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products in April 2021.
Exploring Potential for Reference Materials: SCB is also leading discussions to explore the need for or benefit of reference materials for fiber-based scaffolds.
GET ENGAGED:
To learn more about this initiative, please contact SCB.